BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 2904828 · Received January 9, 2013

    Report

    Report Number
    3005099803-2013-00128
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 14, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WEEKS POST-IMPLANTATION, THE PATIENT RETURNED TO THE PHYSICIAN, WHO NOTED THAT THE PATIENT WAS DOING WELL, WITH NO ISSUES. ONE WEEK LATER, THE PATIENT RETURNED TO THE PHYSICIAN AGAIN, WHO NOTED THAT THE PATIENT WAS STILL DOING WELL AND HAD NO ISSUES. PER THE PHYSICIAN, THE PATIENT HAS NOT FOLLOWED-UP WITH THE PHYSICIAN SINCE THIS APPOINTMENT, AND THE PATIENT HAS NEVER REPORTED OF HAVING ANY COMPLICATIONS. ACCORDING TO THE PHYSICIAN, ALL OTHER INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12755 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other